CN215960097U

CN215960097U - Vascular closure device

Info

Publication number: CN215960097U
Application number: CN202122312530.8U
Authority: CN
Inventors: 不公告发明人
Original assignee: Hangzhou Juzheng Medical Technology Co ltd
Current assignee: Hangzhou Juzheng Medical Technology Co ltd
Priority date: 2021-09-23
Filing date: 2021-09-23
Publication date: 2022-03-08
Anticipated expiration: 2031-09-23

Abstract

The present application provides a vascular closure device having opposite distal and proximal ends, the vascular closure device comprising: an inner tube; a balloon in communication with the distal end of the inner tube; a tip end member connected to a distal side of the balloon, the tip end member being a bendable rod-shaped and coaxially arranged with the inner tube; the plugging piece is movably sleeved on the inner tube and is positioned at the proximal end side of the balloon; the middle tube is sleeved outside the inner tube in a sliding mode and is positioned on the near end side of the plugging piece, and the end head of the far end of the middle tube is a working end used for extruding the plugging piece to deform; the outer tube is sleeved outside the middle tube in a sliding mode, and the far end portion of the outer tube is a loading section used for loading the plugging piece. The blood vessel closing device provided by the application shortens the hemostasis time and relieves the pain of patients.

Description

Vascular closure device

Technical Field

The present application relates to the field of medical device technology, and in particular to vascular closure devices.

Background

Transfemoral puncture is one of the common approaches for vascular interventional procedures, and the same-operation vascular complications at the puncture site are always problems that every interventionalist has to face from time to time. The method for stopping bleeding of the puncture point after femoral artery intervention comprises the following steps: manual compression hemostasis, mechanical compression hemostasis, etc. The traditional manual compression method has long clinical application time, but the long-time compression hemostasis and bed rest not only increase the labor amount of medical personnel, but also increase the pain of patients.

SUMMERY OF THE UTILITY MODEL

To the deficiency of prior art, this application provides a vascular closure device, can shorten hemostasis time, alleviates the disease misery.

The present application provides a vascular closure device having opposite distal and proximal ends, the vascular closure device comprising:

an inner tube;

a balloon in communication with the distal end of the inner tube;

a tip end member connected to a distal side of the balloon, the tip end member being a bendable rod-shaped and coaxially arranged with the inner tube;

the plugging piece is movably sleeved on the inner tube and is positioned at the proximal end side of the balloon;

the middle tube is sleeved outside the inner tube in a sliding mode and is positioned on the near end side of the plugging piece, and the end head of the far end of the middle tube is a working end used for extruding the plugging piece to deform;

the outer tube is sleeved outside the middle tube in a sliding mode, and the far end portion of the outer tube is a loading section used for loading the plugging piece.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the vessel occlusive device further comprises a support member within the interior of the balloon, a distal end of the support member extending out of the balloon, the head end member fixedly connected to the support member, the support member further extending proximally through the interior of the inner tube.

Optionally, the head end piece is configured in a manner that:

the inner core is externally coated with a high polymer material coating layer, and the inner core and the support piece are of an integral structure; or

The metal wire is spirally wound to form a cylindrical structure, and the near end of the cylindrical structure is fixedly sleeved on the support; or

The side wall of the metal tube is provided with a hollow structure, and the near end of the metal tube is fixedly sleeved on the support piece.

Optionally, the vascular closure device further comprises an outer tube seat fixedly connected to the proximal end of the outer tube;

the inner tube seat extends out of the near end of the inner tube, and the inner tube seat is fixed at the extending part.

Optionally, the side wall of the loading section of the outer tube is provided with a deformation release incision, and the blood vessel closing device further comprises an outer sheath, wherein the outer sheath is slidably mounted outside the outer tube to close or expose the deformation release incision.

Optionally, the blocking piece is made of water-absorbing expansion material.

Optionally, the blocking piece is sheet-shaped, and is sleeved on the inner tube after being folded in a circuitous manner.

Optionally, the blocking piece is cylindrical and has an opening gap in a side wall, and the opening gap is formed around the outer periphery of the inner tube from the side of the inner tube.

Optionally, a limiting member is fixed to the outer wall of the inner tube, and the outer tube seat is matched with the limiting member to limit the limit position of the outer tube moving to the distal end.

Optionally, the intermediate tube is sleeved outside the limiting member and is in slidable interference fit in an initial state, the intermediate tube moves to a far end and exposes the working state of the limiting member, in the working state, the working end of the intermediate tube is matched with the balloon to extrude the blocking member to deform, and the far end of the intermediate tube is limited by the limiting member to establish a stroke of the intermediate tube moving to a near end.

The blood vessel closing device provided by the application shortens the hemostasis time and relieves the pain of patients.

Drawings

FIG. 1 is a schematic structural diagram of an embodiment of the present application;

FIG. 2 is a schematic view of the distal end of the outer tube of FIG. 1;

FIG. 3 is a schematic structural view of an embodiment of the closure of FIG. 2;

FIG. 4 is a schematic structural view of another embodiment of the closure of FIG. 2;

FIG. 5 is a side view of FIG. 4;

FIG. 6 is a schematic view of the balloon portion at the distal end of the inner tube shown in FIG. 1;

FIG. 7 is a schematic structural view of an embodiment of the header assembly of FIG. 1;

FIG. 8 is a schematic structural view of another embodiment of the header assembly of FIG. 1;

FIG. 9 is a schematic structural view of another embodiment of the header assembly of FIG. 1;

FIG. 10 is a schematic view of another use state of the present application;

FIG. 11 is a schematic view of another use state of the present application;

FIG. 12 is a schematic view of another use state of the present application;

FIG. 13 is a schematic view of another use state of the present application;

FIG. 14 is a schematic view of another use state of the present application;

FIG. 15 is a schematic view of another use state of the present application;

FIG. 16 is a proximal cross-sectional view of the present application in a use configuration;

fig. 17 is a proximal cross-sectional view of another use condition of the present application.

The reference numerals in the figures are illustrated as follows:

1. an inner tube; 11. an inner tube seat; 12. an extension tube; 13. an inflation joint; 14. a limiting member; 2. a balloon; 21. a support member; 3. a head end piece; 31. a coating layer; 32. a tubular structure; 33. a metal tube; 34. a hollow structure; 35. a round plug; 4. a blocking member; 41. opening the gap; 5. an intermediate pipe; 51. a working end; 6. an outer tube; 61. a loading section; 62. an outer tube seat; 63. an outer sheath; 7. a sheath tube; 71. an instrument channel; 8. skin; 9. a blood vessel; 91. and (6) perforating.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Puncture holes can be left in blood vessels through a blood vessel puncture operation, and the traditional compression hemostasis method has overlong hemostasis time, so that pain of patients is caused.

In view of the above, the present application provides a vascular closure device that can reduce the hemostasis time.

Referring to fig. 1 to 17, the vascular closure device of the present application, having opposite distal and proximal ends, comprises an inner tube 1, a balloon 2, a head end piece 3, a blocking piece 4, an intermediate tube 5, an outer tube 6. The method can be applied to the vascular closure of puncture operations, and can also be applied to the vascular closure of other operation types such as incision operations and the like. The distal and proximal ends of the present application are referred to the vascular closure device itself, and the direction in which the distal or proximal end points may change when the spatial state of the vascular closure device changes. In the hemostatic surgical state, the proximal end refers to the end of the vascular closure device that faces the surgeon, and the distal end refers to the end of the vascular closure device that faces the patient.

The balloon 2 is communicated with the distal end of the inner tube 1, the balloon 2 is made of flexible materials, and the balloon 2 has a contraction state shown in fig. 10 and an expansion state shown in fig. 6. The distal end of the inner tube 1 may extend to the balloon 2 and may also pass through the balloon 2 on the distal side of the balloon 2. In this embodiment, the inner tube 1 may be a hollow tube or a solid tube. When the inner tube 1 is a hollow tube, fluid such as air, physiological saline and the like can be injected into the saccule 2 through the inner cavity of the inner tube 1 to expand the saccule 2. When the inner tube 1 is a solid tube, a fluid can be injected into the balloon 2 through a gap between the inner tube 1 and the balloon 2.

A tip end member 3 is attached to the distal end side of the balloon 2, and the tip end member 3 is a flexible rod-shaped member and is arranged coaxially with the inner tube 1. The puncture channel through the skin 8 forms a certain included angle with the trend of the blood vessel 9, and the sacculus 2 can be guided to enter the inside of the blood vessel 9 through the bending deformation of the head end piece 3 or the bending of the head end piece 3 relative to the sacculus 2, so that the damage of the sacculus 2 to the blood vessel 9 in the entering process is reduced.

The blocking piece 4 is movably sleeved on the inner tube 1 and is positioned at the proximal end side of the balloon 2. The movement of the plugging member 4 may be sliding of the whole plugging member 4 relative to the inner tube 1, or may be deformation of the plugging member 4 to move a part of the plugging member 4 relative to the inner tube 1. The gap between the closure 4 and the balloon 2 can be adjusted by movement of the closure 4 or the shape of the closure 4 can be changed.

The middle tube 5 is slidably sleeved outside the inner tube 1 and is positioned at the proximal end side of the plugging piece 4, and the distal end of the middle tube 5 is a working end 51 for extruding the plugging piece 4 to deform. The outer tube 6 is slidably sleeved outside the middle tube 5, and the distal end part of the outer tube 6 is a loading section 61 for loading the plugging member 4.

The material of the outer pipe 6 can be selected from PI, PEBAX, PA and the like, and the outer diameter of the outer pipe 6 is 5-7F so as to be matched with common sheath pipes in the market. The material of the middle tube 5 can be selected from PI, PEBAX, PA and the like, and the outer diameter of the middle tube 5 is smaller than the inner diameter of the outer tube 6 and is arranged in the outer tube 6. The inner tube 1 can be selected from PI, PEBAX, PA, PT, etc., and the outer diameter of the inner tube 1 is smaller than the inner diameter of the middle tube 5, and the length is longer than the outer tube 6 and the middle tube 5. The balloon can be made of selected materials such as PA, PE, PEBAX, PET and the like; the diameter of the balloon after filling is 3-8 mm, and the optimal diameter is 5 mm. The full inflation pressure of the balloon 2 needs to be above 5atm, but must not exceed 16 atm.

There are various methods of operation of this embodiment, one of which is described below.

After the intervention is completed, the distal end of the sheath 7 enters the blood vessel, the proximal end of the sheath 7 is exposed to the outside of the body through the skin, and an instrument channel 71 is formed in the sheath 7. In hemostasis, the inner tube 1 is first inserted into the blood vessel 9 along the instrument channel 71, and the balloon 2 is extended out of the distal end of the sheath 7. The balloon 2 is now in a deflated state, as shown in fig. 10.

The balloon 2 is filled with a fluid to bring the balloon 2 into an inflated state as shown in fig. 11. The sheath 7 is withdrawn and the loading section 61 of the outer tube 6 is brought close to the outside of the blood vessel 9. At this point the closure member 4 is in the loading section 61 and is protected from contamination, as shown in figure 12.

The outer tube 6 is withdrawn, the distal end of the intermediate tube 5 is exposed and the closure member 4 remains in place. At this time, the perforation 91 is located between the balloon 2 and the blocking member 4, the blocking member 4 is not deformed, and the perforation 91 is not blocked, as shown in fig. 13.

The middle tube 5 is pushed to the far end along the inner tube 1, the gap between the saccule 2 and the plugging piece 4 is reduced, the saccule 2 is gradually attached to the inner wall of the blood vessel 9, and the plugging piece 4 is gradually attached to the outer wall of the blood vessel 9. The intermediate tube 5 is pushed further, and the intermediate tube 5 presses the blocking piece 4 to deform and block the through hole 91, as shown in fig. 14 and 15.

The vascular closure device further comprises a support member 21, the support member 21 being located inside the balloon 2, the distal end of the support member 21 protruding out of the balloon 2, the head member 3 being fixedly connected to the support member 21, the support member 21 further extending proximally via the inside of the inner tube 1. The support 21 is hollow or solid, and the compliance of the head end piece 3 is improved by the support 21.

The head end piece 3 may be constructed in a variety of ways. In a first configuration, as shown in fig. 7, the core is covered with a polymer material coating layer 31, and the core and the supporting member 21 are integrally formed. The materials of the coating 31 are: TPU, PTFE, PEBAX, and the like. In a second configuration, as shown in fig. 8, the wire is helically wound into a tubular structure 32, and the proximal end of the tubular structure 32 is fixedly sleeved to the support member 21. Alternative materials for the tubular structure 32 are: platinum-tungsten alloy, stainless steel, and the like. In a third embodiment, as shown in fig. 9, a metal tube 33 with a hollow-out structure 34 on the side wall is fixedly secured to the support member 21 at the proximal end of the metal tube 33. The metal tube 33 can be selected from the following materials: nitinol, stainless steel, etc. The distal end of the nose end piece 3 is provided with a round plug 35.

The vascular closure device further comprises an outer tube base 62 and an inner tube base 11, the outer tube base 62 being fixedly connected to the proximal end of the outer tube 6, the proximal end of the inner tube 1 extending out of the outer tube base 62, the inner tube base 11 being fixed to the extended portion. The sizes of the inner tube seat 11 and the outer tube seat 62 accord with the ergonomic design, the holding is convenient, the pushing action of the outer tube 6 or the advancing and retreating action of the inner tube 1 relative to the outer tube 6 can be completed by one hand, and the operation is more flexible.

An extension tube 12 is connected to the inner tube base 11, the far end of the extension tube 12 is in butt joint with the inner tube 1, and the near end of the extension tube 12 is connected with an inflation connector 13. The balloon 2 can be inflated by means of an inflation connection 13.

The side wall of the loading section 61 of the outer tube 6 is provided with a strain relief notch (not shown). During loading of the occluding member 4 into the loading section 61 from the distal side of the outer tube 6, the deformation-releasing slit is opened. After the plugging piece 4 is arranged in the loading section 61, the loading section 61 recovers deformation, the deformation releases the incision to shrink, and interference fit is formed between the plugging piece 4 and the loading section 61. The vascular closure device further includes an outer sheath 63, and the outer sheath 63 is slidably mounted to the outside of the outer tube 6 to close or expose the deformation releasing incision. The deformation releasing incision is closed by the sheath 63, preventing the blocking member 4 from being contaminated.

In order to ensure the sealing effect, the plugging piece 4 is made of water-absorbing expansion material. The shape and mounting of the block piece 4 can be varied. In a first installation mode, as shown in fig. 3, the blocking member 4 is sheet-shaped, and is wrapped around the inner tube 1 after being folded. As shown in fig. 4 and 5, in the second attachment method, the closing member 4 is cylindrical and has an open gap 41 in a side wall thereof, and is closed around the outer periphery of the inner tube 1 from the side of the inner tube 1 through the open gap 41. The cylindrical closure 4 may optionally be crimped with a sheet material, either in a single layer or in multiple layers.

The occluding member 4 may be a bioabsorbable material such as collagen. The ratio of the dimensions before and after compression (expansion ratio) is greater than 2:1, for example 10: 1. The water-absorbing expansion material has excellent plugging effect, thereby achieving the hemostatic effect. The bio-absorbable material can be degraded in human tissues and has high safety. The hemostasis time can reach 5 minutes at the shortest.

As shown in fig. 14, 16 and 17, the limiting member 14 is fixed on the outer wall of the inner tube 1, and the outer tube holder 62 is matched with the limiting member 14 to limit the limit position of the distal movement of the outer tube 6.

The intermediate tube 5 is slidably fitted with an interference fit over the stopper 14 in an initial state as shown in fig. 16. The intermediate tube 5 has an operative condition moving distally and exposing the stop, as shown in fig. 17. In the working state, the working end of the intermediate tube 5 cooperates with the balloon 2 to press the plugging member 4 to deform, and the distal end of the intermediate tube 5 is limited by the limiting member 14 to establish the stroke of the intermediate tube moving towards the proximal end. After the action of pushing the plugging member 4 shown in fig. 14, the stopper 14 is extended from the inside of the intermediate pipe 5, and enters the operation state shown in fig. 17. One or more limiting members 14 may be provided in the axial direction or the circumferential direction, and the movement stroke of each tube d is ensured within a safe range by the limiting members 14.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. Vascular closure device having opposite distal and proximal ends, characterized in that it comprises:

an inner tube;

a balloon in communication with the distal end of the inner tube;

2. The vasculature closure device of claim 1 further comprising a support inside the balloon with a distal end of the support protruding out of the balloon, the head end piece being fixedly connected to the support, the support further extending proximally through the inside of the inner tube.

3. The vascular closure device according to claim 2, wherein the head end piece is configured in such a way that:

4. The vasculature closure device of claim 1 further comprising an outer tube holder fixedly attached to the proximal end of the outer tube;

5. The vasculature closure device of claim 1 wherein the loading section of the outer tube has a shape-changing relief cut in a sidewall thereof, the vasculature closure device further comprising an outer sheath slidably mounted to an exterior of the outer tube to close or expose the shape-changing relief cut.

6. The vasculature closure device of claim 1 wherein the occluding member is of a water-swellable material.

7. The vasculature closure device of claim 1, wherein the occluding member is sheet-like and is threaded over the inner tube after being folded around.

8. The vascular closure device according to claim 1, wherein the occluding member is cylindrical and has a sidewall with an open gap through which it is drawn around the outer circumference of the inner tube from the side of the inner tube.

9. The vasculature closure device of claim 1 wherein the outer wall of the inner tube is secured to a stop, and the outer tube seat cooperates with the stop to limit the extreme position of distal movement of the outer tube.

10. The vascular closure device according to claim 9, wherein the intermediate tube is slidably fitted over the stopper in an initial state, the intermediate tube has an operating state in which it moves distally and exposes the stopper, in which the operating end of the intermediate tube cooperates with the balloon to compress the blocking member to deform, and the distal end of the intermediate tube is constrained by the stopper to establish a proximal movement stroke of the intermediate tube.